Reduce unilateral tremor with Exablate
- Trial ID
- NCT04991831
- Official Title
- A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
- Goal
- Reduce unilateral tremor with Exablate
- Status
- RECRUITING
- Sponsor
- InSightec
- Study Type
- OBSERVATIONAL
- Enrollment
- 50 participants
- Conditions
- Tremor Associated With Tremor Dominant Parkinson's Disease
- Interventions
- Unilateral thalamotomy
Plain-Language Summary
The goal is to follow people with tremor-dominant Parkinson's whose tremor does not respond to medications, to see how well a one-sided procedure controls that disabling tremor over time. It uses the Exablate MR-guided focused ultrasound system to heat and destroy a very small area in the motor thalamus on one side of the brain, reducing tremor on the opposite hand without opening the skull. Because the procedure targets the brain circuit that produces tremor, it does not change how levodopa works for other Parkinson's symptoms, though better tremor control may reduce the need for extra tremor medicines. Adults aged 30 to 99 who are already scheduled to receive a unilateral Exablate thalamotomy as part of their usual care and who can sign consent and attend follow-up visits are eligible to join this registry.
Locations
- Miami Neuroscience Institute Baptist Health, Miami, Florida, United States
- Rush University, Chicago, Illinois, United States
- Brigham and Women's Hospital, Boston, Massachusetts, United States
- Weill Cornell Medicine, New York, New York, United States
- Novant Health Brain & Spine Surgery, Huntsville, North Carolina, United States
- Cleveland Clinic Foundation, Cleveland, Ohio, United States
- Miami Valley Hospital, Fairborn, Ohio, United States
- University of Dundee, Dundee, Scotland, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Unilateral thalamotomy. The goal is to follow people with tremor-dominant Parkinson's whose tremor does not respond to medications, to see how well a one-sided procedure controls that disabling tremor over time. It uses the Exablate MR-guided focused ultrasound system to heat and destroy a very small area in the motor thalamus on one side of the brain, reducing tremor on the opposite hand without opening the skull. Because the procedure targets the brain circuit that produces tremor, it does not change how levodopa works for other Parkinson's symptoms, though better tremor control may reduce the need for extra tremor medicines. Adults aged 30 to 99 who are already scheduled to receive a unilateral Exablate thalamotomy as part of their usual care and who can sign consent and attend follow-up visits are eligible to join this registry.
- Who can participate?
- Participants must be between 30 Years and 99 Years.
- Where is this trial located?
- This trial is recruiting at 8 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 7 months.